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Showing results for tags 'Medical device'.
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Content Article
Ineffective medical device recalls are a patient safety scandal
Kath Sansom posted an article in Women's health
A medical device is any piece of equipment, material or apparatus used to diagnose or treat a medical condition. When a medical device is recalled because of safety concerns, it can affect a large number of patients, often on a global scale. However, manufacturers and regulators of these devices don’t often have effective ways to ensure patients know about safety concerns, understand the risks or know what to do if their medical device is recalled. This blog by Kath Samson, founder of the Sling the Mesh campaign, looks at some of the issues around medical device recalls. She suggests ways that device manufacturers and regulators can improve their communication with patients and healthcare staff when a medical device is recalled.- Posted
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Content Article
Transvaginal mesh timeline (7 December 2017)
Patient-Safety-Learning posted an article in Women's health
This blog sets out a timeline of the major landmarks for transvaginal surgical mesh since its first approval in 1996. -
Content Article
Endoscopy safety: Staff attitudes survey
Patient Safety Learning posted an article in Medical devices (existing)
The Joint Advisory Group on GI Endoscopy (JAG) and Imperial College London are conducting a survey into the safety attitudes of all endoscopy staff across UK & Ireland endoscopy services. Your views are vital in understanding current safety practices across endoscopy nationally. This survey takes less than 7 minutes to complete. -
Content ArticleThe Medical Device Safety Officer role was created on 20 March 2014 following the publication of an NHS England Patient Safety Alert that aimed to help healthcare providers increase the quality and frequency of incident reporting for medication errors and medical devices problems. The alert called on large healthcare provider organisations across both public and independent sectors, along with healthcare commissioners, to identify named responsible persons in both medication and medical device safety roles. A new National Network was set up to support Medical Device Safety Officers through improved communication and feedback on reported safety issues, monthly webinars, online forums, conferences and workshops. An editorial board was established to provide expert and strategic clinical support for the Medical Device Safety Officers and the National Network. This handbook provides practical information and resources to support those who have been designated the Medical Device Safety Officer in their organisation. It is particularly relevant to people new in post or as a quick reference for established staff.
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Content ArticleBev Curtis, Medical Device Safety Officer (MDSO) at Harrogate & District NHS Foundation Trust, describes the role of the MDSO in this presentation.
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Content ArticleUnknown to its hypertension specialists, a major teaching hospital changed the cuffs on its sphygmomanometers from manufacturer-validated to a uniform washable alternative, in line with ‘Health and Safety’ concerns surrounding potential cross-contamination between patients. When clinic doctors suspected serious under-reading with the new cuffs, a systematic comparison was undertaken in 54 patients using two UM-101 sphygmomanometers: one using the original, manufacturer-supplied cuff and the other with the washable replacement. The study confirmed an average under-reading of 8±10/5±5 mm Hg using the washable cuff, and a third of patients with poorly controlled hypertension were considered normotensive, after using this cuff. The UM-101 sphygmomanometers have now been re-fitted with the original cuffs. Sphygmomanometer cuffs are not interchangeable between devices and a modicum of common sense should be shown to prevent changes made in the name of Health and Safety from having the opposite effect to that intended.
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Content ArticleThe purpose of this document from the Medicines and Healthcare products Regulatory Agency (MHRA) is to provide information and guidance to all involved with the purchase, management and use of non-invasive blood pressure measurement devices. It reviews the advantages and disadvantages of mercury, aneroid, electronic manual sphygmomanometers and automated blood pressure measuring devices. This should help to ensure the most appropriate technology is selected for use.
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Content ArticleMaybe your blood pressure has been creeping up over time, or you’re starting treatment for hypertension. So your doctor suggests you buy a home blood pressure monitor to help keep track between office visits. Simple enough, right? But a quick check online reveals hundreds of different models — and even a bunch of apps for your smartphone. How do you even start to sort through all that without, well, spiking your blood pressure? This article highlights six things you need to know.
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Content ArticleBlood pressure (BP) has been measured with a cuff for over a 100 years. Recently, ‘tricorders’ and smartwatches that measure BP without a cuff using pulse transit time (PTT) have become available. These BP measurements are based on the inverse relationship between BP and PTT. PTT can be measured as the timing delay in a QRS complex on an EKG and the onset of a photoplethysmography wave, for example measured from a finger. Since these measurements are relatively more user‐friendly than conventional cuff‐based measurements they may aid in more frequent BP monitoring. Using a guidelines‐based protocol, Bard et al. investigated the accuracy and precision of two popular PTT‐based BP measuring devices: the Everlast TR10 fitness watch (Everlast, New York City, NY) and the BodiMetrics tricorder (BodiMetrics, Manhattan Beach, CA).
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Content ArticleThe Medicines and Medical Devices Bill has received royal assent and has become law. The new Act will enable the Department of Health and Social Care (DHSC) to implement a number of policies to amend the existing regulatory frameworks, although generally regulations under the Act must first be introduced. The potential changes include: Supporting the availability of medicines: enabling hub and spoke arrangements between different legal entities, to ‘support wider use of automation to bring increased efficiencies’; requiring manufacturers to provide electronic patient information leaflets; and increasing the professions able to prescribe and supply certain medicines. Protecting the public: developing a UK medicines verification system; introducing a national registration scheme for online sellers of medicines; and facilitating supply of medicines and medical devices during non-pandemic public health emergencies.
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Content ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
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Content Article
In this opinion piece, Kath Sansom, Founder of the Sling the Mesh Campaign, argues that the UK regulatory systems for medicines and healthcare have not been fit for purpose for a number of years. Framed within the context of the Cumberlege Review, Kath uses evidence and personal insight to highlight flaws in the system, and to make the case for urgent reform. -
Content Article
ECRI: Top 10 patient safety concerns 2021
Patient Safety Learning posted an article in International patient safety
ECRI Institute's Top 10 patient Safety concerns for 2021 report highlights patient safety concerns across the continuum of care because patient safety strategies increasingly focus on collaborating with other provider organisations, community agencies, patients or residents, and family members. Each patient safety concern on this list may affect more than one setting and involve a wide range of personnel. -
Content Article
Mesh: Denial, half-truths and the harms (March 2021)
Patient Safety Learning posted an article in Women's health
In this article, Sharon Hartles, a member of the Harm and Evidence Research Collaborative, critically discusses the harmful impacts of mesh medical devices against the backdrop of disempowerment, denial and half-truths. Surgical meshes have been in use since the late 19th century. In the mid-20th century the clinical usage of mesh increased. Now, in the early 21st century, procedures involving mesh implantation are common surgeries that are performed around the world. Despite the frequency and worldwide usage of mesh medical devices, the debate about whether or not the benefits outweigh the alleged harms remains highly contested. Read the full article Further recommended reading: Dangerous exclusions: The risk to patient safety of sex and gender bias Healing after harm: A restorative approach to incidents Analysing the Cumberlege Review: Who should join the dots for patient safety? Findings of the Cumberlege Review: informed consent Findings of the Cumberlege Review: patient complaints -
Content ArticleThis directive alert has been issued on the need to confirm intravenous (IV) lines and cannulae have been effectively flushed or removed at the end of the procedure.
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Content ArticleThis patient-centred report from the Regulatory Horizons Council discusses a route to more effective safety assurance through mechanisms that consider the whole product lifecycle, how adverse events are detected or a long time after use of the device and how to trace and recall patients when needed. In addition, this report also considers a number of ways in which use of data and technology can be smarter and to join up digital systems.
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Content Article
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This week the Department of Health and Social Care released the UK Government’s response to the recommendations of the Independent Medicines and Medical Devices Safety Review, sometimes referred to as the Cumberlege Review. In this blog Patient Safety Learning sets out its reflections on this. -
Content Article
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This report is from the Patient Reference Group established to provide advice, challenge and scrutiny to work to develop the government response to the Independent Medicines and Medical Devices Safety (IMMDS) Review, sometimes referred to as the Cumberlege Review. -
Content Article
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This report from the Department of Health and Social Care sets out the Government's response to the recommendations of the Independent Medicines and Medical Devices Safety (IMMDS) Review, sometimes referred to as the Cumberlege Review. -
Content Article
Women's Hour: Baroness Cumberlege (12 July 2021)
PatientSafetyLearning Team posted an article in Women's health
Baroness Julia Cumberlege, produced the First Do No Harm report that looked into two drugs and a medical device which caused women or their babies harm. In this episode of Women's Hour, she joins host Emma Barnett to talk about her anger and frustration at the lack of progress made since the report was published a year ago. The report made a list of nine recommendations to support victims and prevent future, avoidable damage. Eight of these have seen no action. Listen from 31:20 -
Content ArticleThis is the transcript of a backbench debate in the House of Commons regarding the implementation of the recommendations of First Do No Harm report, published by the Independent Medicines and Medical Devices Safety Review on the 8 July 2020, chaired by Baroness Cumberlege (also known as the Cumberlege Review).
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Content ArticleIn this article, Dr Yu Chye Wah discusses medical innovation in healthcare, the adoption process and how, whatever the innovation, it should not replace the human touch.
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Content ArticleThere is concern among patients, surgeons and health authorities regarding reported adverse patient outcomes following use of mesh in certain urogynaecological surgical procedures. The European Society of Coloproctology (ESCP) has conducted an extensive review of the surgical literature on the outcome of use of mesh in the pelvis of patients who have undergone bowel surgery and will shortly publish its recommendations. ESCP would like to hear from patients who have had both good and not so good experiences with colorectal surgery using mesh such as operations for rectal prolapse (rectopexy), or operations for advanced rectal cancer/inflammatory bowel disease who had mesh inserted to assist in skin closure of the back passage area. The survey is designed to capture the experience of patients who have had an operation that involved using mesh in the pelvis as a part of a colorectal (bowel) surgical operation. The survey is NOT designed to cover outcomes following urogynaecological operations for prolapse or urinary incontinence. The use of mesh as part of abdominal wall hernia repair is also not included.
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Content ArticleImproving the design of technology relies in part, on the reporting of performance failures in existing devices. Healthcare has low levels of formal reporting of performance and failure of medical equipment. This paper from Tase et al. examines methods of reporting in the car industry and healthcare and aims to understand differences and identify opportunities for improvement within healthcare.
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Content ArticleSharps injuries (SI) and mucocutaneous exposures (MCE), collectively termed “blood and body fluid exposure” (BBFE), pose a diseases-transmission risk and a psychological stress to health care workers and a responsibility on employers to prevent their occurrence. However, little UK national data is published on their incidence. The Royal College of Nursing (RCN) present results from a survey of their members.
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